WO1996009844A1 - Method and apparatus for administering a drug to a patient - Google Patents

Method and apparatus for administering a drug to a patient Download PDF

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Publication number
WO1996009844A1
WO1996009844A1 PCT/GB1995/002296 GB9502296W WO9609844A1 WO 1996009844 A1 WO1996009844 A1 WO 1996009844A1 GB 9502296 W GB9502296 W GB 9502296W WO 9609844 A1 WO9609844 A1 WO 9609844A1
Authority
WO
WIPO (PCT)
Prior art keywords
patient
liquid
drug
plunger
diluent
Prior art date
Application number
PCT/GB1995/002296
Other languages
French (fr)
Inventor
Anthony William Manicom
Original Assignee
Manicom, Fiona, Doreen, Patricia
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Manicom, Fiona, Doreen, Patricia filed Critical Manicom, Fiona, Doreen, Patricia
Priority to BR9506400A priority Critical patent/BR9506400A/en
Priority to EP95934702A priority patent/EP0730476A1/en
Priority to AU37020/95A priority patent/AU699592B2/en
Priority to US08/647,942 priority patent/US5755692A/en
Priority to RU96114994A priority patent/RU2138302C1/en
Publication of WO1996009844A1 publication Critical patent/WO1996009844A1/en

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/145—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons
    • A61M5/1452—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons
    • A61M5/1456—Pressure infusion, e.g. using pumps using pressurised reservoirs, e.g. pressurised by means of pistons pressurised by means of pistons with a replaceable reservoir comprising a piston rod to be moved into the reservoir, e.g. the piston rod is part of the removable reservoir
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M2005/1401—Functional features
    • A61M2005/1405—Patient controlled analgesia [PCA]
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A90/00—Technologies having an indirect contribution to adaptation to climate change
    • Y02A90/10—Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Definitions

  • This invention relates to a method of and apparatus for administering a drug to a patient.
  • PCA and PCS patient controlled analgesia and sedation
  • PCA and PCS systems must be carefully designed to avoid the possibility of accidents or deliberate overdoses.
  • Such equipment should also be simple to use.
  • the advantages of patient responsive liquid medium delivery systems and the background to the development of such a system are described in some detail in US Patent 5,065,668 which is incorporated herein by way of reference.
  • prior art systems known to applicant tend to be costly and complex which makes the use of such systems inappropriate for use in less affluent or sophisticated societies. Indeed, it would be desirable for the system to be widely available, possibly even on an out patient basis, but in that event the system would need to incorporate safety features which would protect the patient against overdose as a consequence of malfunction or misuse.
  • a method of administering a drug to a patient comprises the steps of:
  • step (d) repeating steps (b) and (c) from time to time so that a plurality of diminishing doses of the drug are administered to the patient.
  • the dispenser is a syringe, the plunger of which is operated with a reciprocating movement from time to time to administer the predetermined volume of the liquid to the patient, and to draw an equal volume of the diluent into the syringe from a diluent reservoir.
  • the preferred arrangement is for the diluent to be drawn into the dispenser prior to the administration of the liquid to the patient.
  • the travel of the plunger may be constant for each reciprocation thereof.
  • the plunger may be moved by an electromechanical actuator such as a servomotor or a solenoid in response to an electrical drive signal.
  • an electromechanical actuator such as a servomotor or a solenoid in response to an electrical drive signal.
  • apparatus for administering a drug to a patient comprises:
  • support means for supporting a syringe, the syringe having a cylinder and a plunger movable in the cylinder;
  • actuator means engagable with the plunger to move it into and out of the cylinder
  • control means for generating drive signals at intervals to which the actuator means is responsive to cause a reciprocating movement of the plunger in the cylinder from time to time, thereby to cause the plunger to perform a delivery stroke during which a quantity of a liquid in the cylinder is expelled, and an intake stroke in which a quantity of a diluent liquid is drawn into the cylinder.
  • the actuator means may comprise a solenoid or servomotor arranged to move the plunger a predetermined distance into and out of the cylinder during each reciprocation thereof, so that an equal volume of liquid is expelled from and drawn into the cylinder during each reciprocation.
  • the intake stroke may take place prior to the delivery stroke so that diluent liquid is drawn into the syringe prior to delivery.
  • a time delay facility may be incorporated into the control means to provide for a time delay between the intake stroke and the delivery stroke to allow for mixing of drug and diluent prior to delivery.
  • the apparatus preferably includes operating means operable by a patient to generate a demand signal to which the control means is responsive to generate the drive signal.
  • the control means may include timing means for determining a minimum duration of the intervals between the generation of each drive signal.
  • the apparatus may include display means for displaying data indicative of the amount of the original liquid remaining in or dispensed from the syringe, corresponding to the overall dose of the drug in the liquid remaining or already dispensed from the syringe, or which indicates the number of operations of the actuator.
  • Figure 1 is a schematic illustration of an arrangement for exercising the method of the invention, incorporating apparatus according to the invention
  • Figure 2 is a graph illustrating schematically the relative magnitude of successive doses of a drug aclministered to a patient using the method of the invention
  • Figure 3 is a partial sectional side view of the apparatus of the invention.
  • Figure 4 is a plan view of the apparatus of Figure 3;
  • FIG. 5 is a simplified block schematic diagram of the electronic circuitry of the apparatus of Figures 3 and 4;
  • FIG. 6 is a simplified flow chart illustrating the operation of the apparatus in use. DESCRIPTION OF EMBODIMENTS
  • a patient 10 is fitted with a catheter 12 which is connected via a flow control device 14 to a T-connector 16.
  • An injection port at one branch of the T-connector receives the needle 18 of a syringe 20, while the other branch of the T is connected to a drip bag 22 of saline solution or another diluent via a flow control device 24.
  • the syringe 20 is mounted on apparatus according to the invention, illustrated schematically at 26, which is operated by the patient in a patient controlled analgesia (PCA) or patient controlled sedation (PCS) scheme to administer a drug to the patient.
  • PCA patient controlled analgesia
  • PCS patient controlled sedation
  • the syringe 20 is primed with a predetermined volume of a drug in liquid form which is equal to, say, ten times the estimated first dose requirement. All air is expelled from the syringe, which is then coupled to the injection port of the T-piece 16 and then clamped or clipped to the apparatus 26. If necessary, the plunger 28 of the syringe is withdrawn, entraining infusion fluid.
  • the flow control device 24 is adjusted to control the infusion flow rate to a rate sufficient to allow flushing of any drug released from the syringe to the patient.
  • the apparatus 26 is illustrated physically in Figures 3 and 4, while its electronic circuitry is illustrated in Figure 5.
  • the apparatus comprises a housing 30, typically a two-part plastics box. Fixed to the upper surface 32 of the box are a pair of spring clips 34 and 36, and a slotted retaining formation 38 which is shaped to receive the base flange 40 of the syringe cylinder, so that the syringe is positively located on the apparatus in use.
  • a drive element 42 in a form of a plastics plate, with a slot 44 in which the end flange 46 of the syringe plunger 28 is located.
  • the apparatus has three controls, being a push button or bell push 48 connected to the housing by a cable 50, operable by the patient to cause the apparatus to dispense a dose of the drug, a "reset” push button 52 and a "read” push button 54.
  • the apparatus includes a display 56 which is typically a 4-character miniature alphanumeric display.
  • an electromechanical actuator typically a servomotor 58, with a drive link 60 connected pivotally to the drive element 42.
  • a servomotor is useful in that it can be adjusted to cause movement of the drive member 42 which is repeatable, but which can be varied by the control circuitry of the apparatus for different requirements.
  • a solenoid with a repeatable stroke could be used instead.
  • the operation of the servomotor 58 is controlled by an electronic circuit 62 which is powered by a battery 64.
  • the electronic circuitry is illustrated schematically in Figure 5, and comprises a microcontroller 66, which in the prototype was a type PIC16C71 device.
  • the electronic circuitry includes a first power control circuit 68 with a voltage reference circuit 70, which monitors the battery output voltage and compares it with a 1.2 volt reference voltage, to ensure that the supply voltage to the circuit is adequate.
  • the circuit also includes a second power control or drive circuit 72 which in the prototype comprise power transistors which deliver current pulses to the servomotor 58 in response to control signals from the microcontroller 66.
  • the microcontroller 66 has an integral ROM and RAM memory, with a program to control the operation of the apparatus being stored in the ROM.
  • the re-set button 52 is pressed, which resets the dose count displayed on the display 56 and enables the apparatus.
  • the display and other non-essential circuits are powered down, and the microcontroller enters a "sleep" state in which it waits for a demand signal from the push button 48.
  • the microcontroller When a demand signal is detected, the microcontroller outputs a pulse train with a first pulse width, causing the drive circuit 72 to operate the servomotor and thus to withdraw the drive element 42 a predetermined distance, causing an intake stroke of the plunger and drawing into the cylinder a predetermined volume of the diluent into the cylinder of the syringe. The microcontroller will then hold the plunger in this position for a period of approximately five seconds to allow mixing of drug and diluent within the cylinder of the syringe.
  • the microcontroller After the intake stroke, the microcontroller outputs a pulse train with a second pulse width, causing the drive element 44 to reverse its movement, and causing the plunger to perform a delivery stroke.
  • the delivery stroke is of the same length as the intake stroke so that the volume of drug and diluent mix dispersed is the same as the volume of diluent drawn into the syringe. It is preferred that the intake stroke takes place before the delivery stroke so that during the "lock out" phase referred to below the drug has sufficient time to pass into the patient before the next intake stroke takes place. This prevents the drug being drawn back into the syringe from the catheter 12 during the intake stroke. It would, of course, be possible to reverse the order of the strokes by incorporating a one ⁇ way valve into the catheter 12 near to the syringe.
  • a "lock out" timer operates, disabling the apparatus for a predetermined period, typically 5 minutes in the case of PCA applications, or 1 minute in the case of PCS applications using short acting drugs, during which period the apparatus will not respond to further operation of the patient control button 48. This prevents a patient from deliberately or inadvertently administering an excessive dose of the drug.
  • the lock out period provides the time required for flushing the drug to the patient even with relatively slow flowing infusions.
  • the micro processor reverts to its "sleep" cycle, waiting for a further demand signal from the patient control push button 48.
  • the first demand signal would result in delivery of 1.5mg of the drug
  • the second demand would result in delivery of 1.35mg
  • successive doses would be 1.22mg, 1.09mg, 0.98 mg, 0.89mg, and so on.
  • the microcontroller counts the number of operations of the servomotor, and can generate a display of the number of actuations of the device, or can calculate either the amount of the drug administered or remaining in the syringe.
  • the described apparatus uses relatively small drug quantities, and has an inherent immunity to accidental siphonage, it is relatively safe compared with presently used large reservoir techniques, where serious overdosage is possible.
  • the device does not require to be programmed, so that the likelihood of operator error by medical staff is also reduced.
  • the device can be constructed so as to operate with standard sterile syringes so that no special container or sterilization apparatus is required.
  • the simplicity of the drive system and control arrangement will be nmediately apparent enabling the apparatus to be constructed inexpensively.
  • the inherent safety of the system and its low cost makes the system attractive for use in many applications but particularly in less affluent communities where patient care cost is an important consideration when deciding what treatment a patient will be given.

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

A method of administering a drug to a patient comprises the steps of filling a dispenser (20) with a predetermined total volume of a liquid containing the drug and administering a predetermined volume of the liquid in the dispenser to the patient (10). The liquid in the dispenser is then replaced with a diluent (22). The administration of liquid and replacement with diluent (22) are then repeated from time to time so that diminishing doses of the drug are administered to the patient (10). Preferably, the diluent (22) is drawn into the dispenser (20) prior to the drug containing liquid being administered. The method is preferably patient (10) controlled via control push button (48). The invention extends to apparatus which is used to carry out the method.

Description

METHOD AND APPARATUS FOR ADMINISTERING A DRUG TO A PATIENT
BACKGROUND OF THE INVENTION
This invention relates to a method of and apparatus for administering a drug to a patient.
The use of patient controlled analgesia and sedation (PCA and PCS) has gained acceptance in the medical field, but PCA and PCS systems must be carefully designed to avoid the possibility of accidents or deliberate overdoses. Such equipment should also be simple to use. The advantages of patient responsive liquid medium delivery systems and the background to the development of such a system are described in some detail in US Patent 5,065,668 which is incorporated herein by way of reference. However, prior art systems known to applicant tend to be costly and complex which makes the use of such systems inappropriate for use in less affluent or sophisticated societies. Indeed, it would be desirable for the system to be widely available, possibly even on an out patient basis, but in that event the system would need to incorporate safety features which would protect the patient against overdose as a consequence of malfunction or misuse.
SUMMARY OF THE INVENTION
According to the invention a method of administering a drug to a patient comprises the steps of:
(a) filling a dispenser with a predetermined total volume of a liquid containing the drug;
(b) administering a predetermined volume of the liquid in the dispenser to the patient;
(c) replacing the volume of liquid administered to the patient with a diluent; and
(d) repeating steps (b) and (c) from time to time so that a plurality of diminishing doses of the drug are administered to the patient.
Preferably, the dispenser is a syringe, the plunger of which is operated with a reciprocating movement from time to time to administer the predetermined volume of the liquid to the patient, and to draw an equal volume of the diluent into the syringe from a diluent reservoir. The preferred arrangement is for the diluent to be drawn into the dispenser prior to the administration of the liquid to the patient.
The travel of the plunger may be constant for each reciprocation thereof.
The plunger may be moved by an electromechanical actuator such as a servomotor or a solenoid in response to an electrical drive signal.
Further according to the invention apparatus for administering a drug to a patient comprises:
support means for supporting a syringe, the syringe having a cylinder and a plunger movable in the cylinder;
actuator means engagable with the plunger to move it into and out of the cylinder; and
control means for generating drive signals at intervals to which the actuator means is responsive to cause a reciprocating movement of the plunger in the cylinder from time to time, thereby to cause the plunger to perform a delivery stroke during which a quantity of a liquid in the cylinder is expelled, and an intake stroke in which a quantity of a diluent liquid is drawn into the cylinder.
The actuator means may comprise a solenoid or servomotor arranged to move the plunger a predetermined distance into and out of the cylinder during each reciprocation thereof, so that an equal volume of liquid is expelled from and drawn into the cylinder during each reciprocation. The intake stroke may take place prior to the delivery stroke so that diluent liquid is drawn into the syringe prior to delivery. A time delay facility may be incorporated into the control means to provide for a time delay between the intake stroke and the delivery stroke to allow for mixing of drug and diluent prior to delivery.
The apparatus preferably includes operating means operable by a patient to generate a demand signal to which the control means is responsive to generate the drive signal.
The control means may include timing means for determining a minimum duration of the intervals between the generation of each drive signal.
The apparatus may include display means for displaying data indicative of the amount of the original liquid remaining in or dispensed from the syringe, corresponding to the overall dose of the drug in the liquid remaining or already dispensed from the syringe, or which indicates the number of operations of the actuator. BRIEF DESCRIPTION OF THE DRAWINGS
The invention will now be described in more detail, by way of example only, with reference to the accompanying drawings in which:
Figure 1 is a schematic illustration of an arrangement for exercising the method of the invention, incorporating apparatus according to the invention;
Figure 2 is a graph illustrating schematically the relative magnitude of successive doses of a drug aclministered to a patient using the method of the invention;
Figure 3 is a partial sectional side view of the apparatus of the invention;
Figure 4 is a plan view of the apparatus of Figure 3;
Figure 5 is a simplified block schematic diagram of the electronic circuitry of the apparatus of Figures 3 and 4; and
Figure 6 is a simplified flow chart illustrating the operation of the apparatus in use. DESCRIPTION OF EMBODIMENTS
Referring first to Figure 1, a patient 10 is fitted with a catheter 12 which is connected via a flow control device 14 to a T-connector 16. An injection port at one branch of the T-connector receives the needle 18 of a syringe 20, while the other branch of the T is connected to a drip bag 22 of saline solution or another diluent via a flow control device 24.
The syringe 20 is mounted on apparatus according to the invention, illustrated schematically at 26, which is operated by the patient in a patient controlled analgesia (PCA) or patient controlled sedation (PCS) scheme to administer a drug to the patient.
The syringe 20 is primed with a predetermined volume of a drug in liquid form which is equal to, say, ten times the estimated first dose requirement. All air is expelled from the syringe, which is then coupled to the injection port of the T-piece 16 and then clamped or clipped to the apparatus 26. If necessary, the plunger 28 of the syringe is withdrawn, entraining infusion fluid. The flow control device 24 is adjusted to control the infusion flow rate to a rate sufficient to allow flushing of any drug released from the syringe to the patient.
The apparatus 26 is illustrated physically in Figures 3 and 4, while its electronic circuitry is illustrated in Figure 5. The apparatus comprises a housing 30, typically a two-part plastics box. Fixed to the upper surface 32 of the box are a pair of spring clips 34 and 36, and a slotted retaining formation 38 which is shaped to receive the base flange 40 of the syringe cylinder, so that the syringe is positively located on the apparatus in use.
Towards one end of the housing is a drive element 42 in a form of a plastics plate, with a slot 44 in which the end flange 46 of the syringe plunger 28 is located. When the syringe is clamped to the apparatus, the volume of liquid in the syringe is approximately nine tenths of its nominal capacity.
The apparatus has three controls, being a push button or bell push 48 connected to the housing by a cable 50, operable by the patient to cause the apparatus to dispense a dose of the drug, a "reset" push button 52 and a "read" push button 54. The apparatus includes a display 56 which is typically a 4-character miniature alphanumeric display.
Within the housing is an electromechanical actuator, typically a servomotor 58, with a drive link 60 connected pivotally to the drive element 42. A servomotor is useful in that it can be adjusted to cause movement of the drive member 42 which is repeatable, but which can be varied by the control circuitry of the apparatus for different requirements. Instead of a servomotor, a solenoid with a repeatable stroke could be used instead.
The operation of the servomotor 58 is controlled by an electronic circuit 62 which is powered by a battery 64.
The electronic circuitry is illustrated schematically in Figure 5, and comprises a microcontroller 66, which in the prototype was a type PIC16C71 device. In addition to the components already described above, the electronic circuitry includes a first power control circuit 68 with a voltage reference circuit 70, which monitors the battery output voltage and compares it with a 1.2 volt reference voltage, to ensure that the supply voltage to the circuit is adequate. The circuit also includes a second power control or drive circuit 72 which in the prototype comprise power transistors which deliver current pulses to the servomotor 58 in response to control signals from the microcontroller 66.
The microcontroller 66 has an integral ROM and RAM memory, with a program to control the operation of the apparatus being stored in the ROM.
In operation, once the syringe has been fitted to the apparatus, the re-set button 52 is pressed, which resets the dose count displayed on the display 56 and enables the apparatus. Once the apparatus has been initialized, the display and other non-essential circuits are powered down, and the microcontroller enters a "sleep" state in which it waits for a demand signal from the push button 48.
When a demand signal is detected, the microcontroller outputs a pulse train with a first pulse width, causing the drive circuit 72 to operate the servomotor and thus to withdraw the drive element 42 a predetermined distance, causing an intake stroke of the plunger and drawing into the cylinder a predetermined volume of the diluent into the cylinder of the syringe. The microcontroller will then hold the plunger in this position for a period of approximately five seconds to allow mixing of drug and diluent within the cylinder of the syringe.
After the intake stroke, the microcontroller outputs a pulse train with a second pulse width, causing the drive element 44 to reverse its movement, and causing the plunger to perform a delivery stroke. The delivery stroke is of the same length as the intake stroke so that the volume of drug and diluent mix dispersed is the same as the volume of diluent drawn into the syringe. It is preferred that the intake stroke takes place before the delivery stroke so that during the "lock out" phase referred to below the drug has sufficient time to pass into the patient before the next intake stroke takes place. This prevents the drug being drawn back into the syringe from the catheter 12 during the intake stroke. It would, of course, be possible to reverse the order of the strokes by incorporating a one¬ way valve into the catheter 12 near to the syringe.
Once this intake delivery cycle has been completed, a "lock out" timer operates, disabling the apparatus for a predetermined period, typically 5 minutes in the case of PCA applications, or 1 minute in the case of PCS applications using short acting drugs, during which period the apparatus will not respond to further operation of the patient control button 48. This prevents a patient from deliberately or inadvertently administering an excessive dose of the drug. The lock out period provides the time required for flushing the drug to the patient even with relatively slow flowing infusions.
Once the lock out time period has passed, the micro processor reverts to its "sleep" cycle, waiting for a further demand signal from the patient control push button 48.
Due to the fact that a volume of diluent is drawn into the syringe prior to each drug dose being administered, the concentration of the drug in the syringe gradually decreases, and each successive dose administered by the apparatus is slightly smaller, as indicated in Figure 2. The strength of the drug dose delivered by the apparatus decreases exponentially, although the volume dispensed each time is constant. For example, if the syringe were to be primed with 15mg of a sedative drug, and the delivery stroke discharged 10% of the total volume of the syringe, the first demand signal would result in delivery of 1.5mg of the drug, the second demand would result in delivery of 1.35mg, and successive doses would be 1.22mg, 1.09mg, 0.98 mg, 0.89mg, and so on. It is known in the art that a diminishing concentration drug supply arrangement has a number of distinct advantages. See for example US Patent, 4,623,334. The present invention achieves a diminishing supply arrangement but on a patient controlled basis.
The microcontroller counts the number of operations of the servomotor, and can generate a display of the number of actuations of the device, or can calculate either the amount of the drug administered or remaining in the syringe.
The flow chart of Figure 6 summarizes the operation of the apparatus graphically.
Because the described apparatus uses relatively small drug quantities, and has an inherent immunity to accidental siphonage, it is relatively safe compared with presently used large reservoir techniques, where serious overdosage is possible. The device does not require to be programmed, so that the likelihood of operator error by medical staff is also reduced. The device can be constructed so as to operate with standard sterile syringes so that no special container or sterilization apparatus is required. The simplicity of the drive system and control arrangement will be nmediately apparent enabling the apparatus to be constructed inexpensively. The inherent safety of the system and its low cost makes the system attractive for use in many applications but particularly in less affluent communities where patient care cost is an important consideration when deciding what treatment a patient will be given.

Claims

1. A method of administering a drug to a patient comprising the steps of:
(a) filling a dispenser with a predetermined total volume of a liquid containing the drug;
(b) administering a predetermined volume of the liquid in the dispenser to the patient;
(c) replacing the volume of liquid administered to the patient with a diluent; and
(d) repeating steps (b) and (c) from time to time so that a plurality of diminishing doses of the drug are administered to the patient.
2. A method according to claim 1 wherein the dispenser is a syringe, the plunger of which is operated with a reciprocating movement from time to time to administer the predetermined volume of the liquid to the patient, and to draw an equal volume of the diluent into the syringe from a diluent reservoir.
3. A method according to claim 2 wherein the travel of the plunger is constant for each reciprocation thereof.
4. A method according to claim 2 or 3 wherein the diluent is drawn into the dispenser prior to the administration of the liquid to the patient.
5. A method according to claim 4 wherein a time delay takes place between the diluent being drawn into the dispenser and the administration of the liquid to the patient.
6. A method according to any one of claims 2 to 5 wherein the plunger is moved by an electromechanical actuator in response to an electrical drive signal.
7. A method according to any one of claims 1 to 6 wherein the time intervals between repetitions of step (b) are controlled by the patient.
8. A method according to claim 7 wherein the time intervals have a predetermined minimum duration.
9. Apparatus for administering a drug to a patient comprising:
support means for supporting a syringe, the syringe having a cylinder and a plunger movable in the cylinder;
actuator means engagable with the plunger to move it into and out of the cylinder; and
control means for generating drive signals at intervals to which the actuator means is responsive to cause a reciprocating movement of the plunger in the cylinder from time to time, thereby to cause the plunger to perform a delivery stroke during which a quantity of a liquid in the cylinder is expelled, and an intake stroke in which a quantity of a diluent liquid is drawn into the cylinder.
10. Apparatus according to claim 9 wherein the actuator means comprises a solenoid or servomotor arranged to move the plunger a predetermined distance into and out of the cylinder during each reciprocation thereof, so that an equal volume of liquid is expelled from and drawn into the cylinder during each reciprocation.
11. Apparatus according to claim 9 or 10 wherein the control means functions in a manner such that the intake stroke takes place prior to the delivery stroke for each reciprocation.
12. Apparatus according to claim 11 wherein the control means includes an automatic time delay facility for delaying the delivery stroke after the intake stroke has been completed.
13. Apparatus according to any one of claims 9 to 12 including operating means operable by a patient to generate a demand signal to which the control means is responsive to generate the drive signal.
14. Apparatus according to claim 13 wherein the control means includes timing means for determining a minimum duration of the intervals between the generation of each drive signal.
15. Apparatus according to any one of claims 9 to 14 including display means for displaying data indicative of the amount of the liquid remaining in or dispensed from the syringe, or the number of operations of the actuator.
PCT/GB1995/002296 1994-09-28 1995-09-27 Method and apparatus for administering a drug to a patient WO1996009844A1 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
BR9506400A BR9506400A (en) 1994-09-28 1995-09-27 Method and apparatus for administering drugs to a patient
EP95934702A EP0730476A1 (en) 1994-09-28 1995-09-27 Method and apparatus for administering a drug to a patient
AU37020/95A AU699592B2 (en) 1994-09-28 1995-09-27 Method and apparatus for administering a drug to a patient
US08/647,942 US5755692A (en) 1994-09-28 1995-09-27 Method and apparatus for administering a drug to a patient
RU96114994A RU2138302C1 (en) 1994-09-28 1995-09-27 Method and device for infusion of medicine to patient

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ZA94/7542 1994-09-28
ZA947542 1994-09-28

Publications (1)

Publication Number Publication Date
WO1996009844A1 true WO1996009844A1 (en) 1996-04-04

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PCT/GB1995/002296 WO1996009844A1 (en) 1994-09-28 1995-09-27 Method and apparatus for administering a drug to a patient

Country Status (8)

Country Link
US (1) US5755692A (en)
EP (1) EP0730476A1 (en)
AU (1) AU699592B2 (en)
BR (1) BR9506400A (en)
CA (1) CA2177485A1 (en)
RU (1) RU2138302C1 (en)
WO (1) WO1996009844A1 (en)
ZA (1) ZA958073B (en)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1152784A1 (en) * 1999-02-12 2001-11-14 Heiko E.R. Rudolph Method of, and apparatus for, controlling the delivery of a medication
WO2008022792A1 (en) * 2006-08-24 2008-02-28 Fresenius Medical Care Deutschland Gmbh Method and device for filling a supply device of a therapy appliance
WO2009000931A1 (en) * 2007-06-28 2008-12-31 Novapten Method and system for injecting a radioactive product into the body of a patient
GB2560435A (en) * 2017-02-02 2018-09-12 Waqar Majeed Ali Drive apparatus

Families Citing this family (69)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6656157B1 (en) * 1995-04-20 2003-12-02 Acist Medical Systems, Inc. Infinitely refillable syringe
US6449507B1 (en) * 1996-04-30 2002-09-10 Medtronic, Inc. Method and system for nerve stimulation prior to and during a medical procedure
CN1243578C (en) 1998-01-30 2006-03-01 诺沃挪第克公司 An injection syringe
JP3928248B2 (en) * 1998-02-27 2007-06-13 ニプロ株式会社 Chemical liquid self-injection tool
US6752787B1 (en) * 1999-06-08 2004-06-22 Medtronic Minimed, Inc., Cost-sensitive application infusion device
TW453884B (en) 1999-09-16 2001-09-11 Novo Nordisk As Dose setting limiter
US20010041869A1 (en) * 2000-03-23 2001-11-15 Causey James D. Control tabs for infusion devices and methods of using the same
US6471674B1 (en) 2000-04-21 2002-10-29 Medrad, Inc. Fluid delivery systems, injector systems and methods of fluid delivery
EP1280579B1 (en) * 2000-04-28 2013-06-19 Cirque Medical Incorporated Multi-lumen intravenous extension
US6663602B2 (en) * 2000-06-16 2003-12-16 Novo Nordisk A/S Injection device
GB0130138D0 (en) 2001-12-18 2002-02-06 Dca Design Int Ltd Improvements in an relating to a medicament injection apparatus
GB0130139D0 (en) * 2001-12-18 2002-02-06 Dca Design Int Ltd Improvements in and relating to a medicament injection apparatus
US7527608B2 (en) * 2002-08-12 2009-05-05 Lma North America, Inc. Medication infusion and aspiration system and method
GB0304822D0 (en) 2003-03-03 2003-04-09 Dca Internat Ltd Improvements in and relating to a pen-type injector
US9205197B2 (en) * 2003-03-03 2015-12-08 Sanofi-Aventis Deutschland Gmbh Drug delivery device dose setting mechanism
GB0308267D0 (en) * 2003-04-10 2003-05-14 Dca Design Int Ltd Improvements in and relating to a pen-type injector
US20080119703A1 (en) 2006-10-04 2008-05-22 Mark Brister Analyte sensor
US8626257B2 (en) 2003-08-01 2014-01-07 Dexcom, Inc. Analyte sensor
US7591801B2 (en) 2004-02-26 2009-09-22 Dexcom, Inc. Integrated delivery device for continuous glucose sensor
US8886273B2 (en) 2003-08-01 2014-11-11 Dexcom, Inc. Analyte sensor
US20190357827A1 (en) 2003-08-01 2019-11-28 Dexcom, Inc. Analyte sensor
US7920906B2 (en) 2005-03-10 2011-04-05 Dexcom, Inc. System and methods for processing analyte sensor data for sensor calibration
IL157981A (en) 2003-09-17 2014-01-30 Elcam Medical Agricultural Cooperative Ass Ltd Auto-injector
US9247900B2 (en) 2004-07-13 2016-02-02 Dexcom, Inc. Analyte sensor
US8364230B2 (en) 2006-10-04 2013-01-29 Dexcom, Inc. Analyte sensor
US8364231B2 (en) 2006-10-04 2013-01-29 Dexcom, Inc. Analyte sensor
US11633133B2 (en) 2003-12-05 2023-04-25 Dexcom, Inc. Dual electrode system for a continuous analyte sensor
US8425417B2 (en) 2003-12-05 2013-04-23 Dexcom, Inc. Integrated device for continuous in vivo analyte detection and simultaneous control of an infusion device
US8423114B2 (en) 2006-10-04 2013-04-16 Dexcom, Inc. Dual electrode system for a continuous analyte sensor
US8425416B2 (en) 2006-10-04 2013-04-23 Dexcom, Inc. Analyte sensor
US8287453B2 (en) 2003-12-05 2012-10-16 Dexcom, Inc. Analyte sensor
US8808228B2 (en) 2004-02-26 2014-08-19 Dexcom, Inc. Integrated medicament delivery device for use with continuous analyte sensor
IL160891A0 (en) 2004-03-16 2004-08-31 Auto-mix needle
US7783333B2 (en) 2004-07-13 2010-08-24 Dexcom, Inc. Transcutaneous medical device with variable stiffness
US7713574B2 (en) 2004-07-13 2010-05-11 Dexcom, Inc. Transcutaneous analyte sensor
US7857760B2 (en) 2004-07-13 2010-12-28 Dexcom, Inc. Analyte sensor
ATE444090T1 (en) 2004-10-21 2009-10-15 Novo Nordisk As SELECTION MECHANISM FOR A ROTARY PIN
WO2006045524A1 (en) * 2004-10-21 2006-05-04 Novo Nordisk A/S An injection device with means for signalling the time since the last injection
EP1855744A1 (en) * 2005-02-28 2007-11-21 Novo Nordisk A/S A dose setting mechanism for an injection device
US20060211989A1 (en) * 2005-03-04 2006-09-21 Rhinehart Edward J Fluid delivery systems, devices and methods for delivery of fluids
CN101163514B (en) 2005-04-24 2012-01-25 诺和诺德公司 Injection device
EP1996260B1 (en) 2006-03-10 2015-09-23 Novo Nordisk A/S An injection device having a gearing arrangement
EP1996259B1 (en) 2006-03-10 2012-08-15 Novo Nordisk A/S An injection device and a method of changing a cartridge in the device
JP5226508B2 (en) * 2006-05-16 2013-07-03 ローツェ株式会社 Shuttle type transfer device
US8226618B2 (en) 2006-05-16 2012-07-24 Novo Nordisk A/S Gearing mechanism for an injection device
PL2023982T3 (en) 2006-05-18 2012-11-30 Novo Nordisk As An injection device with mode locking means
US7758416B2 (en) 2006-09-08 2010-07-20 Igt Gaming system having a plurality of simultaneously played wagering games that may trigger a plurality of free games which may be played simultaneously with the wagering games
US8478377B2 (en) 2006-10-04 2013-07-02 Dexcom, Inc. Analyte sensor
US8298142B2 (en) 2006-10-04 2012-10-30 Dexcom, Inc. Analyte sensor
US8275438B2 (en) 2006-10-04 2012-09-25 Dexcom, Inc. Analyte sensor
US8449464B2 (en) 2006-10-04 2013-05-28 Dexcom, Inc. Analyte sensor
US8562528B2 (en) 2006-10-04 2013-10-22 Dexcom, Inc. Analyte sensor
US8447376B2 (en) 2006-10-04 2013-05-21 Dexcom, Inc. Analyte sensor
PL2109474T5 (en) 2007-02-05 2019-07-31 Novo Nordisk A/S Injection button
RU2468829C2 (en) 2007-03-23 2012-12-10 Ново Нордиск А/С Injection device comprising lock nut
US20080306434A1 (en) 2007-06-08 2008-12-11 Dexcom, Inc. Integrated medicament delivery device for use with continuous analyte sensor
EP4159114B1 (en) 2007-10-09 2024-04-10 DexCom, Inc. Integrated insulin delivery system with continuous glucose sensor
US8396528B2 (en) 2008-03-25 2013-03-12 Dexcom, Inc. Analyte sensor
WO2010023303A1 (en) * 2008-08-29 2010-03-04 Novo Nordisk A/S Medical injection device with time delay indicator
IT1398348B1 (en) * 2010-03-05 2013-02-22 Tsabari DEVICE FOR THE ADMINISTRATION OF FLUIDS IN AN ANIMAL BODY, PARTICULARLY FOR THE ADMINISTRATION OF THERAPEUTIC AGENTS THROUGH ENDOVASAL INFUSION
AU2011261296C1 (en) 2010-06-04 2016-08-18 Bayer Healthcare, Llc. System and method for planning and monitoring multi-dose radiopharmaceutical usage on radiopharmaceutical injectors
EP2697650B1 (en) 2011-04-15 2020-09-30 Dexcom, Inc. Advanced analyte sensor calibration and error detection
JP6069351B2 (en) 2011-12-29 2017-02-01 ノボ・ノルデイスク・エー／エス Torsion spring type automatic syringe with dial-up / dial-down administration mechanism
EP2862587A1 (en) 2013-10-15 2015-04-22 Becton Dickinson France Tip cap assembly for closing an injection system
KR101667192B1 (en) * 2015-02-27 2016-10-18 (주)이화바이오메딕스 Liquid medicine infuser and liquid medicine supply device including the same
PE20211202A1 (en) 2017-08-24 2021-07-05 Novo Nordisk As COMPOSITIONS OF GLP-1 AND ITS USES
EP3700416B1 (en) 2017-10-24 2024-06-26 Dexcom, Inc. Pre-connected analyte sensors
US11331022B2 (en) 2017-10-24 2022-05-17 Dexcom, Inc. Pre-connected analyte sensors
WO2021144476A1 (en) 2020-02-18 2021-07-22 Novo Nordisk A/S Pharmaceutical formulations

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4196730A (en) * 1977-08-01 1980-04-08 Wilson Dennis R Liquid drug dispenser
GB2066669A (en) * 1980-01-07 1981-07-15 Keeri Szanto M Controlling and monitoring motorised syringe
EP0556878A2 (en) * 1988-10-14 1993-08-25 Becton, Dickinson and Company Thermoelectric chiller and automatic syringe
EP0619122A1 (en) * 1993-04-08 1994-10-12 Getz Bros. Co.,Ltd. Syringe control system for DSA and PTCA

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3515127A (en) * 1967-05-19 1970-06-02 Ralph D Reymond Manostat pump
US4065230A (en) * 1975-01-17 1977-12-27 Hart Associates, Inc. Reciprocating infusion pump and directional adapter set for use therewith
US4273122A (en) * 1976-11-12 1981-06-16 Whitney Douglass G Self contained powered injection system
US4475666A (en) * 1981-08-31 1984-10-09 American Hospital Supply Corporation Automated liquid dispenser control
US5188604A (en) * 1989-09-29 1993-02-23 Rocky Mountain Research, Inc. Extra corporeal support system
US5069668A (en) * 1990-07-12 1991-12-03 Boydman Scott A Patient controlled analgesia system

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4196730A (en) * 1977-08-01 1980-04-08 Wilson Dennis R Liquid drug dispenser
GB2066669A (en) * 1980-01-07 1981-07-15 Keeri Szanto M Controlling and monitoring motorised syringe
EP0556878A2 (en) * 1988-10-14 1993-08-25 Becton, Dickinson and Company Thermoelectric chiller and automatic syringe
EP0619122A1 (en) * 1993-04-08 1994-10-12 Getz Bros. Co.,Ltd. Syringe control system for DSA and PTCA

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1152784A1 (en) * 1999-02-12 2001-11-14 Heiko E.R. Rudolph Method of, and apparatus for, controlling the delivery of a medication
EP1152784A4 (en) * 1999-02-12 2005-04-27 Heiko E R Rudolph Method of, and apparatus for, controlling the delivery of a medication
WO2008022792A1 (en) * 2006-08-24 2008-02-28 Fresenius Medical Care Deutschland Gmbh Method and device for filling a supply device of a therapy appliance
US8715214B2 (en) 2006-08-24 2014-05-06 Fresenius Medical Care Deutschland Gmbh Method and device for filling a supply device of a therapy appliance
WO2009000931A1 (en) * 2007-06-28 2008-12-31 Novapten Method and system for injecting a radioactive product into the body of a patient
FR2917981A1 (en) * 2007-06-28 2009-01-02 Novapten Sarl METHOD AND SYSTEM FOR INJECTING A RADIOACTIVE PRODUCT IN THE BODY OF A PATIENT
GB2560435A (en) * 2017-02-02 2018-09-12 Waqar Majeed Ali Drive apparatus

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US5755692A (en) 1998-05-26
EP0730476A1 (en) 1996-09-11
CA2177485A1 (en) 1996-04-04
AU3702095A (en) 1996-04-19
BR9506400A (en) 1997-09-09
RU2138302C1 (en) 1999-09-27
AU699592B2 (en) 1998-12-10
ZA958073B (en) 1996-04-23

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